A Dose-Escalation Study Designed to Evaluate the Tolerability, Safety, Pharmacokinetics (PK), and Efficacy of Chronic Topical Ocular Application of INO-8875 in Adults With Ocular Hypertension or Primary Open-Angle Glaucoma

Inotek Pharmaceuticals

Status and phase: Completed; Phase 2; Phase 1

Conditions: Glaucoma; Ocular Hypertension

Treatments: Drug: INO-8875; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01123785

IPC-10-2009

Details and patient eligibility

About

The purpose of this study is to evaluate how tolerable, safe, and effective it is to give INO-8875 eye drops to adults with glaucoma or ocular hypertension.

Enrollment: 144 patients

Sex: All

Ages: 18 to 77 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject has the diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG).
2. Aged 18 to 75 years.
3. Mean intraocular pressure (IOP) of ≥24 and ≤34 mm Hg.

Exclusion criteria

1. No significant visual field loss or any new field loss within the past year.
2. Cup-to-disc ratio ≥0.8
3. Central corneal thickness <500 µm or >600 µm
4. History of adult asthma or chronic obstructive pulmonary disease
5. A recent (acute) or chronic medical condition that might obfuscate the Subject's study data

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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144 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Matched vehicle-control

Treatment:

Drug: Placebo

INO-8875

Experimental group

Description:

Adenosine agonist eye drop

Treatment:

Drug: INO-8875